(21 days)
Yes
The device description mentions the use of a "model of bone structures derived from an a priori image data set" for interactive 3D measurement tools. While not explicitly using terms like "AI" or "ML," the concept of deriving a model from a dataset to aid in analysis is consistent with machine learning approaches, particularly model-based segmentation or analysis. The description of the training set further supports this interpretation.
No
The device is intended for analysis and measurement of images, not for treating conditions.
Yes
The device is described as aiding in the "analysis of scoliosis and related disorders and deformities" and "lower limbs alignment and deformities," which are objectives of diagnostic devices.
No
The device is described as a "Workstation," which typically implies a hardware component (computer) running the software. While the summary focuses on the software's functionality, it doesn't explicitly state that the device is only the software and does not include the hardware. Furthermore, it mentions processing images obtained from the "EOS imaging's EOS System," which is a separate hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The sterEOS Workstation processes and analyzes 2D X-ray images of the musculoskeletal system. This is an imaging-based diagnostic tool, not a test performed on biological samples.
- Intended Use: The intended use clearly states its purpose is for processing and analyzing X-ray images to aid in the analysis of skeletal deformities.
Therefore, the sterEOS Workstation falls under the category of medical imaging software or a picture archiving and communication system (PACS) with advanced analysis capabilities, not an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The relevant text section says "Not Found."
Intended Use / Indications for Use
The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopediativ and adult populations as a general device for acceptance, transfer, display, storage, and digital processing of 2D X-ray images of the musculoskeletal system including interactive 2D measurement tools.
When using 2D X-ray images obtained with the EOS imaging EOS System, the sterEOS Workstation provides interactive 3D measurement tools:
- To aid in the analysis of scoliosis and related disorders and deformities of the spine in adult patients. The 3D measurement tools interactive analysis based either on identification of anatomical landmarks for postural assessment or on a model of bone structures derived from an a priori image data set from 175 patients, 47 patients with moderate idiopathic scoliosis and 37 patients with scoliosis), and dry isolated vertebrae data for spine modeling. The model of bone structures is not intended for use to assess individual vertebral abnormalities and is indicated only for patients 7 years and older. For postural assessment, a set of comparative tools is provided allowing the comparison of performed measurements to reference values for patients over 18 years old.
- To aid in the analysis of lower limbs alignment and deformities based on angle and length measurements. The 3D measurement tools include interactive analysis based either on identification of lower limb alignment landmarks or as for the spine, on a model of bone structures derived from an a priori image data set. The model of bone structures is not intended for use to assess individual bone abnormalities. The 3D package including model-based measurements and torsion angles is indicated only for patients 15 years or older. Only the 2D/3D ruler is indicated for measurements in patients younger than 15 years old.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The sterEOS Workstation is a general system for acceptance, transfer, display, storage, and digital processing of 2D X-ray images of the musculoskeletal system, including interactive 2D measurement tools.
When used with 2D X-ray images obtained with the EOS imaging's EOS System (K152788), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of skeletal deformities in spine and lower limbs.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D X-ray images
Anatomical Site
Musculoskeletal system, spine, lower limbs
Indicated Patient Age Range
Pediatric and adult populations.
Spine modeling: patients 7 years and older.
Spinal postural assessment: patients over 18 years old.
Lower limbs 3D package (model-based measurements and torsion angles): patients 15 years or older.
Lower limbs 2D/3D ruler: patients younger than 15 years old.
Intended User / Care Setting
Musculoskeletal radiology and orthopedics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software modifications have been verified at the unit level. After integration, system software verification and validation testing was performed to ensure compliance with specifications, performance and non-regression. Additional performance and functional testing has confirmed the equivalent performance of the modified sterEOS Workstation compared to the predicate sterEOS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 22, 2016
EOS Imaging, Inc. % John J. Smith, M.D., J.D. Regulatory Counsel Hogan Lovells U.S. L.L.P. 555 Thirteenth Street, NW WASHINGTON DC 20004
Re: K160914
Trade/Device Name: sterEOS Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 1, 2016 Received: April 1, 2016
Dear Dr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) K160914
Device Name
sterEOS Workstation
Indications for Use (Describe)
The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopediativ and adult populations as a general device for acceptance, transfer, display, storage, and digital processing of 2D X-ray images of the musculoskeletal system including interactive 2D measurement tools.
When using 2D X-ray images obtained with the EOS imaging EOS System, the sterEOS Workstation provides interactive 3D measurement tools:
- To aid in the analysis of scoliosis and related disorders and deformities of the spine in adult patients. The 3D measurement tools interactive analysis based either on identification of anatomical landmarks for postural assessment or on a model of bone structures derived from an a priori image data set from 175 patients, 47 patients with moderate idiopathic scoliosis and 37 patients with scoliosis), and dry isolated vertebrae data for spine modeling. The model of bone structures is not intended for use to assess individual vertebral abnormalities and is indicated only for patients 7 years and older. For postural assessment, a set of comparative tools is provided allowing the comparison of performed measurements to reference values for patients over 18 years old.
- To aid in the analysis of lower limbs alignment and deformities based on angle and length measurements. The 3D measurement tools include interactive analysis based either on identification of lower limb alignment landmarks or as for the spine, on a model of bone structures derived from an a priori image data set. The model of bone structures is not intended for use to assess individual bone abnormalities. The 3D package including model-based measurements and torsion angles is indicated only for patients 15 years or older. Only the 2D/3D ruler is indicated for measurements in patients younger than 15 years old.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) SUMMARY EOS imaging, Inc.'s sterEOS Workstation
EOS imaging, Inc. 10 rue Mercoeur PARIS F-75011 FRANCE
Phone: + 33 1 55 25 60 60 Facsimile:
Mathias Breuil, Regulatory Affairs Project Leader Contact Person:
Date Prepared: April 1, 2016
Name of Device and Name/Address of Sponsor:
sterEOS Workstation EOS imaging, Inc. 10 rue Mercoeur PARIS F-75011 FRANCE
| Trade Name: | sterEOS Workstation |
|---|---|
| Common or Usual Name: | Image processing radiological system |
| Classification Name: | 21 C.F.R. 892.2050; Picture archiving and communications system |
| Product Code LLZ - system, image processing, radiological | |
| Predicate Device: | 510(k) number: K141137 |
| Trade/Device Name: sterEOS Workstation | |
| Clearance Date: September 15, 2014 | |
| Regulation Number: 21 CFR 892.2050 | |
| Regulation Name: Picture archiving and communications system | |
| Regulatory Class: II | |
| Product Code: LLZ |
Device Description
The sterEOS Workstation is a general system for acceptance, transfer, display, storage, and digital processing of 2D X-ray images of the musculoskeletal system, including interactive 2D measurement tools.
When used with 2D X-ray images obtained with the EOS imaging's EOS System (K152788), the sterEOS Workstation provides interactive 3D measurement tools to aid in the analysis of skeletal
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deformities in spine and lower limbs.
Intended Use/ Indications for Use
The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopedics in both pediatric and adult populations as a general device for acceptance, transfer, display, storage, and digital processing of 2D X-ray images of the musculoskeletal system including interactive 2D measurement tools.
When using 2D X-ray images obtained with the EOS imaging EOS System, the sterEOS Workstation provides interactive 3D measurement tools:
- . To aid in the analysis of scoliosis and related disorders and deformities of the spine in adult patients as well as pediatric patients. The 3D measurement tools include interactive analysis based either on identification of anatomical landmarks for postural assessment or on a model of bone structures derived from an a priori image data set from 175 patients (91 normal patients, 47 patients with moderate idiopathic scoliosis and 37 patients with severe idiopathic scoliosis), and dry isolated vertebrae data for spine model of bone structures is not intended for use to assess individual vertebral abnormalities and is indicated only for patients 7 years and older. For postural assessment, a set of comparative tools is provided allowing the comparison of performed measurements to reference values for patients over 18 years old.
- . To aid in the analysis of lower limbs alignment and related disorders and deformities based on angle and length measurements. The 3D measurement tools include interactive analysis based either on identification of lower limb alignment landmarks or as for the spine, on a model of bone structures derived from an a priori image data set. The model of bone structures is not intended for use to assess individual bone abnormalities. The 3D package including model-based measurements and torsion angles is indicated only for patients 15 years or older. Only the 2D/3D ruler is indicated for measurements in patients younger than 15 years old.
Technological Characteristics
The technological characteristics of the modified sterEOS Workstation are essentially identical to the cleared sterEOS Workstation (K14137). Like the cleared predicate, the subject device is based on the Windows 7 operating system, runs on off-the-shelf hardware, supports DICOM 3.0 formatted images, and has a user interface that follows typical clinical workflow patterns to process, review, and analyze digital images.
The main differences with the cleared sterEOS Workstation consist of the following minor software modifications:
- -Addition of information in the User Manual concerning the patient position on X-ray images for the 3D modeling;
- । Integration of Patient Database module to improve the sterEOS patient list performances and DICOM functionalities;
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- । Simplification of pelvic parameters identification;
- -Reorganization of sterEOS 3D module's lower limbs workflows;
- -Addition of a new clinical parameter in the global posture workflow;
- -Addition of export features to allow for the transfer of sets of data for third-party applications; and
- -Various bug corrections.
Minor hardware modifications were also made to enhance usability.
Performance Data
Software modifications have been verified at the unit level. After integration, system software verification and validation testing was performed to ensure compliance with specifications, performance and non-regression. Additional performance and functional testing has confirmed the equivalent performance of the modified sterEOS Workstation compared to the predicate sterEOS.
Substantial Equivalence
The device has the same intended use and indications, and very similar technological characteristics and principles of operation, as its predicate device. The minor differences between the device and its predicate raise no different questions of safety or effectiveness. Performance data demonstrate that the device is as safe and effective as the company's cleared sterEOS Workstation (K14137) and, thus, is substantially equivalent.